 AnalyticalUtilizing state-of-the-art equipment, our highly skilled analysts support the successful development of your drug candidate. Our expertise in the development of chiral and chemical methods ensures your API meets established quality standards. As your program develops, we manage the qualification and validation of analytical methods to support regulatory filings. Full ICH stability programs complement your comprehensive analytical program.
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- Methods development
- Method transfer protocols
- Qualification & validation
- Reference standard qualification
- Chiral method development
- Structure elucidation
- Impurity characterization
- CFR-21 Part 11 compliant
- UPLC method development
- ICH compliant stability program
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